A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.

Trial Details

NCT ID
NCT07541170
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Divarasib
  • Pembrolizumab
  • Nivolumab
Locations (sample)
  • Clovis, California, United States|36.82523,-119.70292
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Farmington Hills, Michigan, United States|42.48531,-83.37716
  • Reno, Nevada, United States|39.52963,-119.8138
  • Reno, Nevada, United States|39.52963,-119.8138

Key Eligibility Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
  • Participants must have had complete resection of NSCLC
  • Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based double…

For full eligibility, visit ClinicalTrials.gov.

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